Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-24 @ 11:42 PM
NCT ID:
NCT02524951
Eligibility Criteria:
Inclusion Criteria:
* Signed, witnessed, and dated Institutional Review Board (IRB) approved Informed Consent Form (ICF).
* Pathologically confirmed metastatic breast cancer with measurable disease. Metastatic sites must be measurable on CT, MRI, or FDG-PET/CT as per the revised RECIST v1.1 criteria or measurable disease on physical examination.
A metastatic site must be biopsy proven
* Life expectancy ≥3 months.
* Patients enrolled must have received 2 or more lines of therapy and all patients with HER2 expressing tumors must have received HER2 targeted therapy.
* Female Age ≥18 years.
* Stable brain metastasis is permitted. This is not considered measurable disease.
Stable brain metastasis is defined as no change on CT scan or MRI for minimum of 2 months AND no change in steroid dose for a minimum of 4 weeks
* A negative serum pregnancy test, if female of reproductive potential. Reproductive potential defined as age \< 55 or with no menses for \< 1 year
* Screening laboratory values as follows:
Total bilirubin ≤1.5 times upper limit of normal (ULN). Aspartate aminotransferase (serum glutamic oxaloacetic transaminase) and alanine aminotransferase (serum glutamic pyruvate transaminase)≤ 2.5 times ULN.
Serum creatinine ≤2.0 mg/dL or calculated creatinine clearance ≥60 mL/min. Absolute neutrophil count \>1,500 cells/mm3. Platelet count ≥100,000 plt/mm3. Hemoglobin ≥ 8 g/dL. Non-diabetic
Exclusion Criteria:
* Pregnant or breast-feeding
* ECOG Performance Status greater than 2
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT02524951
Study Brief:
Protocol Section:
NCT02524951